Routes of the same type are on the same row. Compare other markets.
11 pathway types exist in both markets: full application, new active substance, full or mixed application, known active substance, generic application, biosimilar application, conditional or accelerated approval, priority or accelerated review and more. The table lines up the routes of each type.
Australia: Registration of a new prescription medicine (standard pathway), 220 days. South Korea: New drug item permit, 70 days. These are official targets, not actual review times.
| Pathway type | Australia | South Korea |
|---|---|---|
| Full application, new active substance | Registration of a new prescription medicine (standard pathway)Type A · target 220 days · fee A$246,401 | New drug item permittarget 70 days · fee ₩410,000,000 Item permit for biological products and vaccinestarget 115 days · fee ₩8,031,000 Item permit for advanced biological products (cell and gene therapy)target 70 days · fee ₩205,000,000 |
| Full or mixed application, known active substance |
Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.
| Generic application | Generic drug item permit (bioequivalence)target 55 days |
| Biosimilar application | Biosimilar item permittarget 115 days · fee ₩310,000,000 |
| Non-prescription application | Registration of a new over-the-counter medicineN1-N5 · fee A$27,500 | - |
| Non-prescription monograph | - |
| Conditional or accelerated approval | Provisional approval pathway for prescription medicinestarget 220 days · fee A$321,446 |
| Priority or accelerated review | Priority review pathway for prescription medicinestarget 150 days · fee A$260,579 | Priority review designation (GIFT)target 90 days |
| Orphan or rare disease designation |
| Reliance route, abridged review | Comparable overseas regulator report-based process, approach ACOR-A · relies on US, EU, GB, CA, CH, JP, SG Comparable overseas regulator report-based process, approach BCOR-B · relies on US, EU, GB, CA, CH, JP, SG | - |
| Reliance route, recognition or verification | Register inclusion of medical devices and IVDs using manufacturer evidencefee A$1,603 · relies on EU, US, CA, JP, SG, GB | - |
| Work-sharing or joint review | Access Consortium work-sharingNASWSI · relies on CA, SG, CH, GB Project Orbis collaborative oncology reviewrelies on US | - |
| Device: premarket notification | Class 1 medical device notificationtarget 5 days In vitro diagnostic device notification (Class 1)target 5 days · fee ₩85,000 Digital medical device notification (Class 1)target 5 days |
| Device: premarket approval by the regulator | - | Medical device permit (Classes 2 to 4)target 80 days · fee ₩98,430,000 In vitro diagnostic device permit (Classes 2 to 4)target 80 days · fee ₩1,495,000 Digital medical device permit or certification (including software)target 80 days · fee ₩1,495,000 |
| Device: conformity assessment by a certification body | Class 2 medical device certificationtarget 5 days · fee ₩130,000 In vitro diagnostic device certification (Class 2)target 5 days · fee ₩130,000 |
| Device: breakthrough or priority program |
| Other route | Inclusion of a Class 2, 3 or 4 biological (cell and tissue products)target 220 days · fee A$314,145 |